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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/26/2021.

Bipolar Plasmakinetic TURP Versus Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Clinicaltrials.gov identifier NCT03936244

Recruitment Status Active, not recruiting

First Posted May 3, 2019

Last update posted May 3, 2019

Study Description

Brief summary:

The study is a randomized controlled trial with 3-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution

  • Condition or Disease:Prostatic Hyperplasia
    Lower Urinary Tract Symptoms
    Transurethral Resection of Prostate
  • Intervention/Treatment: Device: Transurethral Resection of the Prostate (TURP)
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Treatment
  • Official Title: A Randomized Controlled Trial (RCT) for Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate (PK-TURP) With Monopolar Transurethral Resection of the Prostate (M-TURP) in the Treatment of Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
  • Actual Study Start Date: December 2014
  • Estimated Primary Completion Date: December 2017
  • Actual Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: M-TURP
The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator
Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Experimental: PK-TURP
The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator
Device: Transurethral Resection of the Prostate (TURP)
Randomized allocation to M-TURP or PK-TURP
Outcome Measures
  • Primary Outcome Measures: 1. International Prostate Symptom Score (IPSS) [ Time Frame: 36 months ]
    International Prostate Symptom Score (with 7 questions) was measured at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows to categorize the lower urinary tract symptoms (LUTS) in 3 categories Mild LUTS: 0-7 points Moderate LUTS: 8-19 points Severe LUTS: 20-35 points
  • 2. Maximum urinary flow rate (Qmax [ Time Frame: 36 months ]
    Maximum urinary flow rate (mL/s) was measured at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • 3. postvoid residual urine (PVRU) volume [ Time Frame: 36 months ]
    Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • Secondary Outcome Measures: 1. Quality of Life (QoL): bother score item of the IPSS questionnaire [ Time Frame: 36 months ]
    We use the bother score item of the IPSS questionnaire (question 8) measured at the baseline and in 1, 3, 6, 12, 18, 24 and 36 months after the operation to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows to categorize the QoL in 3 categories Good QoL: 0-2 points Intermediate QoL: 3 points Poor QoL: 4-6points
  • 2. Sexual activity [ Time Frame: 36 months ]
    Sexual activity was measured (with yes/no questions) at at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • 3. International Index of Erectile Function (IIEF-5) [ Time Frame: 36 months ]
    International Index of Erectile Function (with 5 questions) was measured at the baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows to categorize the erectile function of patients Without erectile dysfunction: 22-25 points Mild erectile dysfunction: 17-21 points Mild to moderate erectile dysfunction: 12-16 points Moderate erectile dysfunction: 8-11 points Severe erectile dysfunction: 1-7 points
  • 4. Prostate volume (PV) [ Time Frame: 36 months ]
    Prostate volumen was measured by transrectal ultrasound at the baseline and at 12-month postoperatively
  • 5. Operative time [ Time Frame: Up to 24 hours ]
    Operative time (min)
  • 6. Irrigation volume [ Time Frame: Up to 24 hours ]
    Irrigation volume (L)
  • 7. Change in plasmatic sodium in 24 hours post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the sodium loss during operation
  • 8. Change in Haemoglobin in 24 hours post-operation [ Time Frame: 24 hours after surgery ]
    Compared with the baseline, to demonstrate the blood loss during operation
  • 9. Transfusion rate [ Time Frame: 1 month ]
    Transfusion rate (%)
  • 10. Catheter duration [ Time Frame: 1 month ]
    Catheter duration (days)
  • 11. Hospital stay [ Time Frame: 1 month ]
    Hospital stay (days)
  • 12. Resected tissue weigh [ Time Frame: Up to 24 hours ]
    Resected tissue weigh (grams)
  • 13. Resected tissue percentage [ Time Frame: Up to 24 hours ]
    Compared with the baseline, to demonstrate the % of tissue loss during operation
  • 14. Speed resection [ Time Frame: Up to 24 hours ]
    Speed resection (g/min)
  • 15. Early reoperation rate [ Time Frame: 1 month ]
    The ratio of patient who need reoperation because bleeding complications
  • 16. Late reoperation rate [ Time Frame: 36 months ]
    The ratio of patient who need reoperation because residual adenoma, complications
  • 17. Post-TURP syndrome rate [ Time Frame: Up to 24 hours ]
    Post-transurethral resection of the prostate syndrome rate was recorded.
  • 18. Clavien Dindo System [ Time Frame: 36 months ]
    It is a system for evaluating surgical complications at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • 19. Bleeding complications rate [ Time Frame: 1 month ]
    Register the number of events of haematuria and acute urinary retention by clots
  • 20. Urinary tract infections rate [ Time Frame: 36 months ]
    Register the number of urinary tract infections at baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • 21. Stenotic complications rate [ Time Frame: 36 months ]
    Register the number of stenotic complications (meatal stenosis, urethral stricture and bladder neck contracture) at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • 22. Urinary incontinence rate [ Time Frame: 36 months ]
    Register the number of patientes with urinary incontinence (stress and urge incontinence) at baseline and at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
  • 23. Sequelae rate [ Time Frame: 36 months ]
    register the number of sequelas (retrograde ejaculation, dysuria) at 1, 3, 6, 12, 18, 24 and 36-month postoperatively
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Sign the informed consent voluntarily and will be willing to follow-up

- Prostate volume <80 g - Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention) - The use of antiplatelet agents or anticoagulant drugs is allowed. Exclusion Criteria: - Previous history of pelvic surgery - Previous history of pelvic radiotherapy - Previous history of neurogenic bladder dysfunction - Documented or suspected prostate carcinoma - Patients with severe cardiopulmonary disease or severe mental disorders - Poor compliance, and can not be followed up.

Contacts and Locations
Contacts
Locations

Spain, Madrid
Hospital Universitario de Fuenlabrada
Fuenlabrada

Sponsors and Collaborators

Hospital Universitario de Fuenlabrada

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